The guidance also recommends further research for the use of viscoelastometric testing in the management of emergency bleeding in cases of trauma and post-partum haemorrhage because the technologies show promise.

During surgery the blood clotting process (haemostasis) can be disrupted (coagulopathy), resulting in excessive and sometimes life-threatening blood loss. Coagulopathy can occur in a variety of clinical situations including liver transplantation, cardiac surgery, vascular surgery, postpartum haemorrhage and severe trauma. However, coagulopathy cannot currently be easily detected by laboratory coagulation testing.

Viscoelastometric point-of-care testing is a blood test that may be used to determine whether bleeding is a result of coagulopathy or a surgical bleed. It is mainly used in adults who are having major surgery that is associated with high blood loss, such as cardiac surgery, or in adults undergoing emergency surgery for trauma or post-partum haemorrhage. Viscoelastometric testing helps guide the clinician to select the most appropriate treatment to stop the bleeding.

Patients with serious bleeding usually require a blood transfusion and/or re-operation. Cardiac surgery uses approximately 15% of all donated blood in the UKⁱ, and of the 30,000 patients who undergo cardiac surgery each year in the UK, as many as 1200 require re-operation for bleeding.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Current laboratory testing is only able to identify when blood is not clotting properly, not what part of the clotting process is disrupted. By using these new tests, clinicians will be able to determine what has caused a bleed and tailor treatment to the cause of the coagulopathy rather than replacing blood with transfusion, or undertaking a further operation.

"The evidence shows that not only is the use of these tests associated with fewer deaths, but also a reduced probability of experiencing complications, fewer transfusions and lower hospitalisation costs."

The guidance also recommends that further research is carried out into the clinical benefit and cost effectiveness of using a further system – Sonoclot (Sienco Inc.) - for the same indication. Further research was also recommended for the use of all 3 devices in the management of emergency bleeding in cases of trauma and post-partum haemorrhage.

Ends

Notes to Editors

References and explanation of terms

i.  Based on 1,800,000 blood donations each year, with 100 donations equating to 47 litres of blood (NHS Blood & Transfusion website – see http://www.nhsbt.nhs.uk/) cardiac surgery accounts for 127,000 litres of blood annually in the UK

About the guidance

1. The guidance on viscoelastometric point-of-care testing for detecting, managing and monitoring haemostasis is available on the NICE website at http://www.nice.org.uk/Guidance/DG13

2. The guidance also looked at the use of viscoelastometric testing to assist with detecting, managing and monitoring of haemostasis in the surgical management of trauma and post-partum haemorrhage. Because of a lack of evidence for its use for these indications, the draft guidance recommends that further research is undertaken.

About haemostasis/coagulopathy

3. Bleeding is a potential complication of any surgical procedure, and the risk is proportional to the size and complexity of the surgery.

4. High blood loss is associated with certain types of surgery such as cardiac and liver surgeries, certain orthopaedic procedures (such as hip replacement) and obstetric surgery. High blood loss can also occur in people after physical trauma and those experiencing postpartum haemorrhage. Major blood loss occurs frequently and is associated with a marked rise in deaths in hospitals.

5. Haemostasis is the term used to describe the process of blood clotting and the subsequent dissolution of the clot after the injured tissue has been repaired. During haemostasis, 4 steps occur in a rapid sequence. First, vascular constriction of blood vessels occurs to reduce blood loss. Second, platelets become activated by thrombin and aggregate at the site of injury, forming a temporary, loose platelet plug. The protein fibrinogen is primarily responsible for stimulating platelet clumping. Platelets clump by binding to collagen, which becomes exposed after rupture of the endothelial lining of vessels, and the plug covers the break in the vessel wall. The third step is coagulation or blood clotting. This reinforces the platelet plug with fibrin threads that act as a ‘molecular glue’. Finally, the clot must dissolve for normal blood flow to resume after tissue repair. This happens through the action of plasmin. Abnormalities, either acquired or of a genetic origin, in any of these 4 haemostasis steps can lead to bleeding (during and after surgery) or thrombosis.

6. For most surgical procedures, mortality ranges from less than 0.1% for most routine surgery to 1% to 2% for cardiac surgery and 5% to 8% for elective vascular cases. Mortality may be greatly increased when severe bleeding occurs during the operative procedure. 

7. Excessive bleeding (greater than 2 litres) is encountered in 5% to 7% of people undergoing cardiac surgery. If conventional methods to stop bleeding fail, reoperation (in 3.6% to 4.2% cases) may be required. Major blood loss is linked to adverse outcomes and is associated with an eightfold increase in the odds of death. More than 30,000 people have heart surgery in the UK each year.

8. To manage bleeding, early and sufficient blood product support can be given to patients with major blood loss and to those with dilutional coagulopathy. Supportive care with fresh frozen plasma and platelets can be given to patients with severe coagulopathy while the underlying condition is being treated. Patients with haematological disorders such as myelodysplasia or factor VIII inhibitors will need specialist care. Pharmacological agents such as prothrombin complex concentrate, fibrinogen concentrate and recombinant VIIa can be used to increase haemostatic capacity. The guidelines on management of major haemorrhage developed by the British Committee for Standards in Haematology state that fresh frozen plasma, platelet transfusion or cryoprecipitate should be administered to correct coagulopathy when PT or activated partial thromboplastin time is more than1.5 times baseline, platelet count is less than 50 times 109/litre, or fibrinogen level is greater than 1 g/100 ml.

About the NICE Diagnostics Assessment Programme

1. For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance. 
2. Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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